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Last Update: 01/25/16

43 States Push FDA for Warning Labels on Pain Medications for Pregnant Mothers

This month, Florida Attorney General Pam Bondi joined with 42 other Attorneys General from their respective states in sending a joint letter to the Food and Drug Administration (FDA) demanding that something be done to protect babies from being injured or killed in vitro as their mothers ingest “opioid analgesics” during pregnancy.

|  Read the 43 Attorneys General Letter to the FDA here. |

What is an opioid analgesic?

An “opioid analgesic” is a drug.  It can be an illegal drug, like heroin or cocaine, or it can be a prescription drug, like Vicodin.  Analgesics are pain relievers; you can buy them over the counter at any grocery store or gas station.  Opioid analgesics are a special kind of pain medication: they have the boost of “opioid receptors” in them which impact the central nervous system in a big way (hence, stopping pain fast).

Common Opioid Analgesics in the United States Today:

Generic Name – Brand Name

  1. fentanyl – Duragesic
  2. hydrocodone – Norco, Vicodin
  3. hydromorphone – Dilaudid, Exalgo
  4. morphine – Astramorph, Avinza
  5. oxycodone – OxyContin, Percocet

What is the crisis that brought about almost every state attorney general banding together to write the Food and Drug Administration?

Across the country, pregnant women are taking pain medications without being aware of the danger of neonatal withdrawal or neonatal abstinence syndrome (NAS).  Similar to fetal alcohol syndrome, where women ingest alcoholic beverages during pregnancy and then give birth to babies suffering from the permanent effects of that ingestion, NAS (neonatal abstinence syndrome) happens when a pregnant woman takes a pain-killing drug that then enters not only her body but that of the unborn baby via the placenta.

According to state statistics, in 2011 there were 7 babies born out of every 1000 in Florida that were diagnosed with NAS.  And that number is growing.

The result?  NAS babies can experience:

  • Birth defects
  • Low birth weight
  • Premature birth
  • Small head circumference
  • Sudden infant death syndrome (SIDS)

Mothers should be warned by their doctors as well as by health care staff of the dangers of taking pain medication during pregnancy.  However, the number of infants suffering from NAS in this country suggests that there are women in Florida and the rest of the nation that are not aware of the real and dangerous risk of NAS to their child.

Accordingly, state prosecutors are asking that the FDA put warning labels on these pain medications to help make mothers aware of the dangers here.

From Pam Bondi’s news release:

TALLAHASSEE, Fla.–Florida Attorney General Pam Bondi, Kentucky Attorney General Jack Conway, and 41 other attorneys general today sent a letter to the Food and Drug Administration urging them to place a black box warning on opioid analgesics to indicate the risk of Neonatal Abstinence Syndrome. NAS can occur in newborns who are exposed to prescription drugs while in the womb, and symptoms can include tremors, seizures, abdominal pain, incessant crying, and rapid breathing. In 2011, there were 1,563 instances of newborns diagnosed with drug exposure in Florida. While that is a three-fold increase since 2007, NAS is still widely believed to be an underreported problem.

“We must do everything we can to protect babies from the devastating effects of prescription drug abuse by expectant mothers. We recently launched an educational campaign in Florida, and I strongly believe that placing warning labels directly on prescription opiates is another necessary step in protecting the most vulnerable victims of this epidemic,” stated Attorney General Pam Bondi.

Attorney General Bondi, the Department of Children and Families, the Department of Health, and members of the Statewide Task Force on Prescription Drug Abuse and Newborns recently launched a statewide educational campaign designed to prevent babies from being born exposed to prescription drugs. The campaign educates expectant mothers about the importance of discussing prescription drug use with their doctors, and it provides ways to assist women. The campaign includes a helpline at 1-877-233-5656, a website at, video and radio spots, and billboards.

What Should You Do?

A good piece of advice if you have been harmed by a medication error, is to speak with an experienced personal injury lawyer before you file a claim to learn about some of the issues that can arise with these claims, including the type of evidence needed to prove a claim and the type and amount of damages you can recover. Most personal injury lawyers, like Alan Sackrin, will offer a free initial consultation (over the phone or in person) to answer your questions.



Do you have questions or comments? Then please feel free to send Alan an email or call him now at (954) 458-8655.



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